(74 days)
The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body.
The VENX REVOLUTION™ is a sterile, disposable, single patient use surgical instrument for the disruption and destruction of spider veins located in the lower extremities of the body. The device is made available in several sizes to accommodate a range of veins that form in the lower body. The VENX REVOLUTION™ consists of a thermoplastic handle containing a lever actuated rack and gear mechanism for rotating a shaft extending from the handle. At the end of the shaft are stainless steel, needle-like tines sharpened and spaced appropriately to straddle veins located just below the surface of the skin. Once the tines are in place straddling the vein, the levers are actuated causing the shaft to rotate approximately 360° or more. Actuating the levers causes internal springs to compress. Once the levers have rotated the shaft 360° and the tines have disrupted the vein, releasing the levers allows the compressed springs to return the tines to their original position. The device is then withdrawn and re-inserted at another position within the clinician-selected area to repeat the operation on the same vein or on another vein. The procedure is repeated until all veins within the selected area have been treated.
The VENX REVOLUTION is a manual surgical instrument for the disruption and destruction of spider veins in the lower extremities. The device incorporates a lever-actuated mechanism to rotate tines a minimum of 360 degrees.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Supporting Performance |
|---|---|---|---|
| Functional Equivalence | Ability to disrupt and destruct spider veins | Performed as intended and equivalent to the predicate device | Bench testing under simulated actual use conditions |
| Device Integrity/Durability | Tine deformation | Not explicitly detailed as a separate criterion, but included in "Testing" | Bench testing |
| Device Functionality | Cycle life | Not explicitly detailed as a separate criterion, but included in "Testing" | Bench testing |
| Mechanical Operation | Rotating mechanism operation | Not explicitly detailed as a separate criterion, but included in "Testing" | Bench testing |
2. Sample size used for the test set and the data provenance:
The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is "Bench testing... using simulated actual use conditions," which suggests in-vitro testing rather than human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish ground truth for the test set. The evaluation was done through "Bench testing," likely involving engineering and technical assessment rather than clinical expert consensus.
4. Adjudication method for the test set:
No adjudication method is mentioned as there were no human subjects or expert assessments involved in the "Bench testing."
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The testing described is bench testing, not a clinical study involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The concept of "standalone performance" typically applies to AI algorithms. Since this is a manual surgical instrument, this question is not directly applicable. The device itself is a "standalone" mechanical tool, and its performance was assessed in isolation through bench testing.
7. The type of ground truth used:
Given that the study involved "Bench testing using simulated actual use conditions," the "ground truth" would likely be based on physical measurements and engineering specifications related to the device's ability to disrupt simulated veins and its mechanical integrity, rather than expert consensus, pathology, or outcomes data from human subjects. For example, successful disruption of a simulated vein might have been a measurable outcome against a predefined physical standard.
8. The sample size for the training set:
There is no training set as this is a mechanical device undergoing bench testing, not an AI or algorithmic system that requires training data.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device and study.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.